Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
NCT ID: NCT02452866
Last Updated: 2021-04-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
325 participants
INTERVENTIONAL
2015-06-30
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
NCT01262885
Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
NCT00753558
Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
NCT00421187
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
NCT05277350
A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
NCT00000655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SYM-1219
All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole
SYM-1219
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SYM-1219
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
* Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator
* Agree to abstain from alcohol for 3 days following study treatment.
* Have a clinical diagnosis of bacterial vaginosis
* Agree not to use vaginal douches or similar products for the duration of the study.
Exclusion Criteria
* Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).
* Are menopausal as determined by the Investigator
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
* Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator
* Have consumed any alcohol within 12 hours prior to treatment with study medication.
* Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1).
* Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
12 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Symbiomix Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Jonesboro, Arkansas, United States
La Mesa, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Groton, Connecticut, United States
Clearwater, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Plantation, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Roswell, Georgia, United States
Shawnee Mission, Kansas, United States
Baltimore, Maryland, United States
Fall River, Massachusetts, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Saginaw, Michigan, United States
Plainsboro, New Jersey, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Jackson, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYM-1219-350
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.